Mintz Levin - Health Law & Policy Matters

Part D Woes, According to the OIG

On June 23, 2015, the OIG issued two reports focusing on fraud, waste, and abuse in the Part D program, the first “Ensuring the Integrity of Medicare Part D” and the second “Questionable Billing Practices and Geographic Hotspots…more
| Health, Science, Computers, & Technology

FDA Provides 11th Hour Delay of Product Tracing Requirements for Pharmacies

On June 30, 2015, a mere day before the product tracing deadline for dispensers was to go into effect, FDA published a compliance policy guidance that delays enforcement of the applicable product tracing requirements until…more
| Administrative Law, Health, Science, Computers, & Technology

FDA Reports Results of Annual Crack Down on Illegal Internet Pharmacies

Last week, FDA announced that more than 1,050 websites had illegal drugs and devices seized or received warning letters as part of the Eighth Annual International Internet Week of Action (IIWA). IIWA is an international effort…more
| Consumer Protection, Criminal Law, Health, Science, Computers, & Technology

Massachusetts Health Care Regulatory Review – Opportunity for Industry Comment

Health care is big business in Massachusetts, and it is a highly regulated business. But Governor Charlie Baker hopes to simplify the Massachusetts regulatory regime. This past March, Governor Baker initiated a year-long review…more
| Health

HRSA Takes its First Steps on 340B Rules

The 340B Drug Discount Program has operated for more than 20 years with just a few governing regulations codified in 42 CFR Part 10. Through the Affordable Care Act (“ACA”), Congress adopted several amendments to the 340B…more
| Health

Latest Medicare Fraud Strike Force Takedown Is The Most Significant To Date

As we discussed yesterday, the Medicare Fraud Strike Force’s eighth annual nationwide takedown resulted in charges in 17 districts against 243 individuals for approximately $712 in false billings. It is the most significant…more
| Criminal Law, Health

Government Announces Health Care Fraud “Takedown”

Earlier today, Attorney General Loretta Lynch announced the largest coordinated crackdown in the Medicare Fraud Strike Force’s eight-year history. The government brought charges against 243 individuals for approximately $712…more
| Administrative Law, Criminal Law, Health

CMS Finally Releases Proposed Rules for Medicaid Managed Care

On Friday, Mintz Levin Health Law and ML Strategies posted an advisory on CMS’s proposed Medicaid Managed Care rules. This advisory provides contextual background, a helpful overview of the rule’s contents, and an in-depth…more
| Health, Insurance

AMA Ethical Guidelines on Telemedicine Tabled for Further Review

On Monday, during the annual meeting of the American Medical Association (AMA) House of Delegates, the delegates voted to table a proposed measure to adopt ethical guidelines for physicians who provide telemedicine services. The…more
| Health, Professional Malpractice, Science, Computers, & Technology

Physician Compensation Arrangements – OIG Fraud Alert Warns of Potential Anti-kickback Statute Violations

In a fraud alert released today, the OIG warns that physician compensation arrangements, such as medical directorship compensation, may potentially violate the anti-kickback statue. The fraud alert reiterates the “one purpose”…more
| Health

Fingerprint-Based Background Checks Begin August 1st for Medicaid Providers

On June 1st, the Centers for Medicaid and Medicare Services (CMS) released a State Medicaid Director Letter (SMD Letter) providing guidance to states on the criminal background check and fingerprinting requirements for Medicaid…more
| Health

Injunction Blocks Implementation of Texas Telemedicine Regulations

Late last week, Texas telemedicine practitioners received a temporary reprieve from a new regulation issued by the Texas Medical Board (the “Board”) when a Texas federal court prohibited implementation of the new rule that would…more
| Antitrust & Trade Regulation, Constitutional Law, Health, Science, Computers, & Technology

Supreme Court Decides Qui Tam First-to-File Issues

Whether you are on the defense side or the relator side of the qui tam world, you can count the Supreme Court’s opinion in Kellogg, Brown & Root Services, Inc. v. United States ex. Rel. Carter as a win and a loss. Since…more
| Civil Procedure, Government Contracting, Health

OIG Releases Semiannual Report to Congress

The Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) recently released its Semiannual Report to Congress (“Report”), summarizing OIG’s activities for the six-month period ending on March 31,…more
| Health

ACO Model Expansion Hinges on Increasing Medicare Program Flexibility

Earlier this month, HHS Secretary Silvia Burwell made a game-changing announcement about the Obama Administration’s most significant alternative payment model (APM). The Pioneer Accountable Care Organization (Pioneer ACO) model…more
| Business Organizations, Health
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Contact

701 Pennsylvania Avenue, N.W.
Washington, DC 20004-2608, United States

  • 202-434-7324
  • 202-434-7400

Areas of Practice
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